PsoriasisprIMMaNCT04780516
Study to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Psoriasis Treated With Subcutaneous Risankizumab Injection According to Standard of Care
An observational study of Psoriasis, run by AbbVie at 11 sites in Israel.
Trial summary
Psoriasis is a chronic inflammatory skin condition that is characterized by symptoms such as pain, itching and discomfort. This can have severe impact on the quality of life including depression, embarrassment, and social isolation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 141 participants
- Where
- 11 sitesIsrael
- Study dates
- 26 Apr 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with moderate to severe psoriasis who are prescribed risankizumab according to local label prior to enrolling in this study.
Who may be able to join
- Clinical diagnosis of moderate to severe psoriasis.
- Prescribed risankizumab as the standard treatment for psoriasis, according to the local label. The decision to prescribe risankizumab will be made solely by the physician, based on his clinical judgment, and is done prior to any decision to approach the participant to participate in this study.
- Willing to be involved in the study, to sign an informed consent form and complete study questionnaires.
- Participants participating in digital component: Pruritus Numeric Rating Scale (PNRS) score >=4 at baseline.
Who cannot join
- Participants participating in a concurrent clinical interventional study or within 30 days.
- Participants treated with risankizumab prior to baseline visit.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Israel11 sites
HaEmek Medical Center /ID# 251040
Afula, Haifa District, 1834111
Barzilai Medical Center /ID# 229156
Ashkelon, Southern District, 7830604
Soroka University Medical Center /ID# 226570
Beersheba, Southern District, 8410101
Maccabi /ID# 246679
Haifa, 7176250
Shaare Zedek Medical Center /ID# 247319
Jerusalem, Jerusalem, 91031
Rabin Medical Center /ID# 226568
Petah Tikva, 4941492
The Chaim Sheba Medical Center /ID# 226562
Ramat Gan, Tel Aviv, 5265601
Duplicate_Kaplan Medical Center /ID# 226569
Rehovot, Central District, 7661041
Leumit /ID# 252029
Rehovot, Central District, 9458414
ZIV Medical Center /ID# 226565
Safed, Northern District, 13100
Tel Aviv Sourasky Medical Center /ID# 226564
Tel Aviv, Tel Aviv, 6423906
About this study
Official title: Prospective Non-Interventional Study to Investigate the Durable Effectiveness of Risankizumab Using Digital and Remote Evaluation Tools in Moderate to Severe Psoriasis Patients - prIMMa Study
Psoriasis is a chronic inflammatory skin condition that is characterized by symptoms such as pain, itching and discomfort. This can have severe impact on the quality of life including depression, embarrassment, and social isolation. The objective of this study is to evaluate how effective risankizumab is in changing the disease symptoms in adult participants with moderate to severe psoriasis.
Risankizumab is an approved drug being developed for the treatment of psoriasis. Adult participants who are prescribed risankizumab treatment according to the local label will be enrolled in this study. Approximately 125 adult participants with moderate to severe psoriasis will be enrolled at multiple sites across Israel.
Read more
Participants who are prescribed to receive subcutaneous risankizumab injection by their physician according to local label will be enrolled and will be followed for approximately 2 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, patient charts, questionnaires, and remote monitoring device (patch sensor).
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Risankizumab, Skyrizi, prIMMa
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants Treated With Risankizumab | Participants will receive risankizumab (Skyrizi) as prescribed by the physician according to the local label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) 0 or 1
DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment.
Measured: Week 52
Secondary outcomes (11)
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) 0 or 1
DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment.
Measured: Up to approximately 104 weeks
Change From Baseline in Average Nightly Nocturnal Scratch Activity
Average nightly nocturnal scratch activity (number of scratch events, total scratch time, and scratch intensity) will be measured by a digital monitoring device.
Measured: Baseline (Week 0) to Week 52
Percentage of Participants With Physician Assessment Static Psoriasis Global Assessment (sPGA) 0 or 1
Disease duration and disease severity will be assessed by sPGA.
Measured: Up to approximately 104 weeks
Change From Baseline in Average Pruritus Numeric Rating Scale (PNRS)
PNRS is a patient reported score that assesses itch severity on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst imaginable itch".
Measured: Up to approximately 4 weeks
Change From Baseline in Medical Outcome Study Sleep Scale (MOS-SS)
Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache over the past 4 weeks.
Measured: Up to approximately 4 weeks
Change From Baseline in Psoriasis Symptoms Scale (PSS)
PSS is a 4-item scale designed to measure patient-reported psoriasis symptoms. The PSS consists of four items assessing severity of pain, itching, redness, and burning during the past 24 h. A 5-point severity scale was used as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.
Measured: Up to approximately 104 weeks
Change From Baseline in Dermatology Life Quality Index (DLQI)
DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment.
Measured: Up to approximately 104 weeks
Change From Baseline in Work Productivity and Activity Impairment (WPAI)
WPAI measures the effect of general health and symptom severity on work productivity and regular activities during the past 7 days.
Measured: Up to approximately 104 weeks
Percentage of Participants With Change From Baseline DLQI > Minimal Clinically Important Difference (MCID)
DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The MCID is defined as an improvement of >= 5 points in DLQI.
Measured: Up to approximately 104 weeks
Percentage of Participants With Durability of Response Among sPGA Responders ar Week 24
Durability of response is measured by the maintenance of the sPGA 0/1 at weeks 52 and 104.
Measured: Up to approximately 104 weeks
Number of Participants With Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Measured: Up to approximately 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start26 Apr 2021
- Primary completion2 Jan 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780516
- Sponsor's protocol ID
- P20-439
- Acronym
- prIMMa
- Status last verified
- Aug 2025
- First submitted
- 1 Mar 2021
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Snast I, Valdman-Grinshpoun Y, Bathish N, Matz H, Shclar Y, Murad S, Czarnowicki T, Shavit E, Yang L, Goss S, Maor IP, Halperin A, Blonder SN, Cohen R, Bleterman A, Barak M, Pavlovsky L. Effectiveness, Quality of Life and Durability of Risankizumab in Patients with Moderate-to-Severe Psoriasis: Real-World Evidence from the PRIMMA Study. Dermatol Ther (Heidelb). 2026 May;16(5):2525-2540. doi: 10.1007/s13555-026-01729-7. Epub 2026 Mar 31.
PubMed 41915361
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-Interventional Study to Investigate the Durable Effectiveness of Risankizumab Using Digital and Remote Evaluation Tools in Moderate to Severe Psoriasis Patients - prIMMa Study
- ClinicalTrials.gov ID
- NCT04780516
- Acronym / sponsor ID
- prIMMa / P20-439
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Risankizumab, Skyrizi, prIMMa
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 141 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psoriasis is a chronic inflammatory skin condition that is characterized by symptoms such as pain, itching and discomfort. This can have severe impact on the quality of life including depression, embarrassment, and social isolation. The objective of this study is to evaluate how effective risankizumab is in changing the disease symptoms in adult participants with moderate to severe psoriasis.
Risankizumab is an approved drug being developed for the treatment of psoriasis. Adult participants who are prescribed risankizumab treatment according to the local label will be enrolled in this study. Approximately 125 adult participants with moderate to severe psoriasis will be enrolled at multiple sites across Israel.
Participants who are prescribed to receive subcutaneous risankizumab injection by their physician according to local label will be enrolled and will be followed for approximately 2 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, patient charts, questionnaires, and remote monitoring device (patch sensor).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Treated With Risankizumab | – | –Participants will receive risankizumab (Skyrizi) as prescribed by the physician according to the local label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with moderate to severe psoriasis who are prescribed risankizumab according to local label prior to enrolling in this study.
Key inclusion criteria (4 listed)
- Clinical diagnosis of moderate to severe psoriasis.
- Prescribed risankizumab as the standard treatment for psoriasis, according to the local label. The decision to prescribe risankizumab will be made solely by the physician, based on his clinical judgment, and is done prior to any decision to approach the participant to participate in this study.
- Willing to be involved in the study, to sign an informed consent form and complete study questionnaires.
- Participants participating in digital component: Pruritus Numeric Rating Scale (PNRS) score >=4 at baseline.
Key exclusion criteria (2 listed)
- Participants participating in a concurrent clinical interventional study or within 30 days.
- Participants treated with risankizumab prior to baseline visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) 0 or 1
Time frame: Week 52
DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment.
11 secondary outcomes
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) 0 or 1
Time frame: Up to approximately 104 weeks
Change From Baseline in Average Nightly Nocturnal Scratch Activity
Time frame: Baseline (Week 0) to Week 52
Percentage of Participants With Physician Assessment Static Psoriasis Global Assessment (sPGA) 0 or 1
Time frame: Up to approximately 104 weeks
Change From Baseline in Average Pruritus Numeric Rating Scale (PNRS)
Time frame: Up to approximately 4 weeks
Change From Baseline in Medical Outcome Study Sleep Scale (MOS-SS)
Time frame: Up to approximately 4 weeks
Change From Baseline in Psoriasis Symptoms Scale (PSS)
Time frame: Up to approximately 104 weeks
Change From Baseline in Dermatology Life Quality Index (DLQI)
Time frame: Up to approximately 104 weeks
Change From Baseline in Work Productivity and Activity Impairment (WPAI)
Time frame: Up to approximately 104 weeks
Percentage of Participants With Change From Baseline DLQI > Minimal Clinically Important Difference (MCID)
Time frame: Up to approximately 104 weeks
Percentage of Participants With Durability of Response Among sPGA Responders ar Week 24
Time frame: Up to approximately 104 weeks
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 104 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Derived from this study: PubMed 41915361Snast I, Valdman-Grinshpoun Y, Bathish N, Matz H, Shclar Y, Murad S, Czarnowicki T, Shavit E, Yang L, Goss S, Maor IP, Halperin A, Blonder SN, Cohen R, Bleterman A, Barak M, Pavlovsky L. Effectiveness, Quality of Life and Durability of Risankizumab in Patients with Moderate-to-Severe Psoriasis: Real-World Evidence from the PRIMMA Study. Dermatol Ther (Heidelb). 2026 May;16(5):2525-2540. doi: 10.1007/s13555-026-01729-7. Epub 2026 Mar 31.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by AbbVie at 11 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) 0 or 1 (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04780516, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.